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目的:探讨司帕沙星耳用凝胶的制备及建立其质量控制方法。方法:以司帕沙星为主药,以卡波姆-940为基质制备耳用凝胶,采用紫外分光光度法测定其中司帕沙星的含量,并考察制剂的稳定性。结果:在298 nm波长处,司帕沙星检测浓度在2～12μg·ml~(-1)范围内与吸光度呈良好的线性关系(r=0.9999),平均回收率为99.66%,RSD为0.63%(n=5)。室温放置2个月,样品均未发生分层,其颜色、pH及含量均无明显变化。结论:本制剂制备工艺简单、可行,质量控制方法操作快速,结果准确可靠。
Objective: To investigate the preparation of sparfloxacin ear gel and establish its quality control method. Methods: Sparfloxacin as the main drug, carbomer -940 as the base preparation of otic gel, UV spectrophotometry sparfloxacin in which the content, and study the stability of the preparation. Results: At the wavelength of 298 nm, sparfloxacin showed a good linear relationship with absorbance in the range of 2 ~ 12 μg · ml -1 (r = 0.9999), with an average recovery of 99.66% and a RSD of 0.63 % (n = 5). After 2 months of storage at room temperature, no delamination occurred in the samples, and no significant changes in color, pH and content were observed. Conclusion: The preparation of the preparation is simple and feasible, the method of quality control is operated quickly and the result is accurate and reliable.